Gardner Cryogenics
Country not established
- Devices
- 2
What Gardner Cryogenics makes
Gardner Cryogenics manufactures medical gases used for pulmonary function testing (PFT) and calibration gases for blood gas analyzers. These products include specialized gas mixtures designed to validate and standardize diagnostic equipment in clinical and research settings.
The company’s portfolio includes Class I and Class II devices, regulated under the FDA’s 510(k) clearance process. Products are listed in the U.S. and comply with applicable medical device regulations. The manufacturer is based in the United States.
Catalogue
Pft Gases Ref K781523
Regimes: 510(k) Registry: 510(k)Blood Gas Analyzer-Calibration Gas Ref K770494
Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Gardner Cryogenics have in the registry?
The registry currently lists 2 devices for Gardner Cryogenics. Devices recorded under merged duplicate company entries are counted once.
Which registries list Gardner Cryogenics's devices?
Among its 2 most recently registered devices, Gardner Cryogenics has devices listed in FDA 510(k) (2 devices).
What risk classes do Gardner Cryogenics's devices fall under?
Among its 2 most recently registered devices, the classes recorded for Gardner Cryogenics's devices are Class I and Class II. Each device page shows its own class and authorisation.
What are the newest devices from Gardner Cryogenics in the registry?
The most recently registered devices listed for Gardner Cryogenics include PFT GASES and BLOOD GAS ANALYZER-CALIBRATION GAS.